Headaches are a common complaint heard by primary care physicians and account for more than 10 million office visits each year in the United States (US). The American Migraine Study reports that 32 million Americans suffer from at least one migraine headache annually, and that 23 million people in the US suffer from “severe migraines” (Stewart W F JAMA 1992; 267:64 9, Lipton, R B Headache. 2001; 41:638 645). The cost of migraines and their associated symptoms to the US economy is greater than $14 billion per year.
A migraine is a severe headache that is usually recurrent and disabling. More than 85% of women and more than 82% of men with severe headache had some headache-related disability (Stewart W F, JAMA 1992; 267:64 9). Approximately 33% were severely disabled or needed bed rest during an attack. Many who suffer from migraines experience chronic anxiety, fearing the next attack and find their ability to work, to take care of their families, and to meet social obligations is disrupted. Disability, therefore, occurs not only during attacks but also between attacks. Quality of life measurements have shown that those who suffer from migraines, compared to those with other chronic illnesses, have lower scores in physical functioning and role functioning, and also experience more body pain (Dahlof, C Cephalalgia 1993; 13:233-237).
Migraine headaches can induce a number of serious physical conditions, including strokes, aneurysms, permanent visual loss, severe dental problems, coma and even death. Migraine and epileptic seizure disorders are also related, e.g., a migraine-triggered epilepsy. In addition to the physical conditions associated with the migraine headache itself, over-the-counter (OTC) products used by people who suffer from migraines, such as aspirin, acetaminophen, ibuprofen and other common analgesics, exhibit side effects associated with both chronic use and short-term overuse. These side effects are frequently severe and may include liver damage, kidney damage, ulcers and stomach upset. Each year, use of non-steroidal anti-inflammatory drugs such as aspirin and ibuprofen, account for an estimated 7600 deaths and 76000 hospitalizations in the US (Fries J F. Assessing and understanding patient risk. Scand J Rheumatol Suppl. 1992; 92:21 4.). Frequent use of OTC analgesics has been recognized as a substantial contributor to the development of daily headaches (“chronic daily headache”). Rebound headaches are also associated with the use of OrC analgesics, especially with products incorporating caffeine or aspirin.
The triptans are a class of medication frequently used to treat migraines including, for example, Imitrex, Zomig, and Maxalt. The side effects commonly observed with this class of drugs include chest pain, shortness of breath, palpitations, paresthesias, asthenia, dizziness, dry mouth, fatigue, hot flashes, nausea, vomiting, and sleepiness. Less common side effects include chills, constipation, diarrhea, heartburn, joint pain, central nervous system effects (agitation, anxiety, confusion, depression, irritability), eye problems (e.g., blurred vision, dry eyes, irritated eyes), dysphagia, euphoria, heat sensitivity, hypertension, flatulence, increased sweating, increased thirst, polyuria, pruritis, insomnia, muscle stiffness, muscle pain or spasms, tinnitus, tremor, vertigo, and warm or cold sensations.
A study by Lipton, R Headache Vol 41, pp 638 645, August 2001 revealed that more than half of all Americans who suffer from migraine headaches are prepared to put up with the pain rather than seek treatment from a physician, and that 26% had stopped seeing their doctor about the condition because they felt the doctor could not help. Commercially available migraine treatments are associated with a number of disadvantages, including side effects that are often severe. Thus, a treatment for migrainous headaches and the symptoms associated with migrainous headaches that is not only effective at treating but also at preventing migrainous headaches and associated symptoms without side effects would satisfy a great need.